ZAPR™ ZAPR0400
GUDID G507ZAPR04000
Red Blood Cell Lysing Buffer
Incell Corporation, LLC
Blood cell lysis reagent IVD| Primary Device ID | G507ZAPR04000 |
| NIH Device Record Key | 913fcc4b-0ed4-4f0b-8ffe-d2f05d519968 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZAPR™ |
| Version Model Number | ZAPR0400 |
| Catalog Number | ZAPR0400 |
| Company DUNS | 965420953 |
| Company Name | Incell Corporation, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com |
Device Dimensions
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
| Total Volume | 400 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G507ZAPR04000 [Primary] |
FDA Product Code
| GGK | Products, Red-Cell Lysing Products |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-14 |
| Device Publish Date | 2023-09-06 |
On-Brand Devices [ZAPR™]
| G507ZAPR04000 | Red Blood Cell Lysing Buffer |
| G507ZAPR01000 | Red Blood Cell Lysing Buffer |
Trademark Results [ZAPR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZAPR 97284611 not registered Live/Pending |
Takara Bio USA, Inc. 2022-02-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.